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Lung Volume Reduction Coil Treatment in Emphysema. (STICREVOLENS)

Primary Purpose

Emphysema

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Lung volume reduction coïl treatment
Regular medical treatment
Sponsored by
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emphysema focused on measuring Chronic obstructive pulmonary disease, Endoscopic lung volume reduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Bilateral emphysema on Chest CT Scanner
  • Post bronchodilator FEV1 < 50 %
  • Total Lung Capacity > 100 %
  • Residual Volume > 220 %
  • Dyspnea score between 2 and 4 based on the mMRC scale
  • Stopped cigarette smoking for more than 8 weeks
  • Pulmonary rehabilitation within the previous twelve months
  • Consent form signed
  • Covered by Medical Insurance

Exclusion Criteria:

  • Post bronchodilator FEV1 < 15%
  • Post-bronchodilator change in FEV1 > 20%
  • Severe recurrent respiratory infections requiring more than 2 hospitalization stays within the past twelve months
  • COPD exacerbation requiring hospital stay within 3 months
  • Pulmonary Hypertension (Pulmonary systolic pressure >50 mmHg on cardiac echo)
  • Patient unable to perform a 6-min walking test in room air
  • Giant bulla of more than 1/3 of the lung field on Chest CT
  • Strictly homogeneous emphysema on Chest CT
  • Clinically significant bronchiectasis
  • Past history of lobectomy, lung volume reduction surgery, lung transplantation
  • Any extrapulmonary diseases compromising survival or evaluation within the protocol (severe cardiac disease, severe renal insufficiency, cancer…)
  • Lung carcinoma or pulmonary nodule on CT scan requiring Chest CT scan follow-up
  • Contra-indication to general anesthesia
  • Oral anticoagulant treatment (antivitamin K)
  • Allergy to nitinol
  • Inclusion in an other study assessing respiratory treatments
  • Patient protected by the law

Sites / Locations

  • CHU d'Amiens
  • CHU de Grenoble
  • AP-HM
  • CHU de Montpellier
  • CHU de Nice
  • AP-HP - Hôpital Bichat
  • CHU de Rouen
  • CHU de Saint-Etienne
  • Hôpitaux Universitaires de Strasbourg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Lung volume reduction coïl treatment

Regular Medical Treatment

Arm Description

Lung volume reduction coïl treatment,added to usual medical treatment and follow up after the intervention

No intervention, just a follow up under usual medical treatment

Outcomes

Primary Outcome Measures

6-month improvement of the 6-minute walk test
6-month improvement of the 6-minute walk test : the percentage of patients showing an improvement of at least 54m will be compared between groups.

Secondary Outcome Measures

Cost-effectiveness
Cost utility (incremental cost effectiveness ratio) of each therapeutic option according to the EuroQol-5 dimensions (EQ-5D) utility scores.
Dyspnea
Comparison of dyspnea assessed by the mMRC scale, BDI/TDI scale and the Borg scale
Pulmonary function assessment
Pulmonary function tests including FEV1, FVC, RV, TLC, RV/TLC.
Quality of life
Comparison of the St georges questionnaire score and the EuroQoL 5D (European Quality of Life 5 dimensions)
Morbidity-mortality
Comparison of mortality and severe adverse events using a composite score (death, haemoptysis > 150 cc, pneumonia requiring hospitalization, pneumothorax requiring chest tube drainage > 7 days, mechanical ventilation > 24 hours, lung transplantation).

Full Information

First Posted
March 28, 2013
Last Updated
April 29, 2014
Sponsor
CHU de Reims
Collaborators
PneumRx, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01822795
Brief Title
Lung Volume Reduction Coil Treatment in Emphysema.
Acronym
STICREVOLENS
Official Title
Cost-effectiveness of Lung Volume Reduction Coil Treatment in Emphysema.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
Collaborators
PneumRx, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
BACKGROUND: Medical therapeutic options for the treatment of emphysema remain limited. Lung volume reduction surgery is infrequently used because of its high morbi-mortality. Endobronchial lung volume reduction coil (LVRC(®), PneumRx, Mountain View, CA) treatment has been recently developed and has been shown to be feasible and associated with an acceptable safety profile, while resulting in improvements in dyspnea, exercise capacity and lung function. The objective of this study is to analyze the cost effectiveness of LVRC treatment in severe emphysema. METHODS:This prospective, multicenter study, randomized with a 1:1 ratio (LVRC vs conventional treatment) will include 100 patients who will be followed up for 1year. The primary outcome measure is the 6-month improvement of the 6-minute walk test: the percentage of patients showing an improvement of at least 54m will be compared between groups. A cost-effectiveness study will estimate the cost of LVRC treatment, the global cost of this therapeutic option and will compare the cost between patients treated by LVRC and by medical treatment alone. EXPECTED RESULTS:This study should allow validating the clinical efficacy of LVRC in severe emphysema. The cost-effectiveness study will assess the medical-economic impact of the LVRC therapeutic option.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema
Keywords
Chronic obstructive pulmonary disease, Endoscopic lung volume reduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lung volume reduction coïl treatment
Arm Type
Experimental
Arm Description
Lung volume reduction coïl treatment,added to usual medical treatment and follow up after the intervention
Arm Title
Regular Medical Treatment
Arm Type
Other
Arm Description
No intervention, just a follow up under usual medical treatment
Intervention Type
Procedure
Intervention Name(s)
Lung volume reduction coïl treatment
Intervention Type
Other
Intervention Name(s)
Regular medical treatment
Primary Outcome Measure Information:
Title
6-month improvement of the 6-minute walk test
Description
6-month improvement of the 6-minute walk test : the percentage of patients showing an improvement of at least 54m will be compared between groups.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Cost-effectiveness
Description
Cost utility (incremental cost effectiveness ratio) of each therapeutic option according to the EuroQol-5 dimensions (EQ-5D) utility scores.
Time Frame
6 and 12 months
Title
Dyspnea
Description
Comparison of dyspnea assessed by the mMRC scale, BDI/TDI scale and the Borg scale
Time Frame
6 and 12 months
Title
Pulmonary function assessment
Description
Pulmonary function tests including FEV1, FVC, RV, TLC, RV/TLC.
Time Frame
6 and 12 months
Title
Quality of life
Description
Comparison of the St georges questionnaire score and the EuroQoL 5D (European Quality of Life 5 dimensions)
Time Frame
6 and 12 months
Title
Morbidity-mortality
Description
Comparison of mortality and severe adverse events using a composite score (death, haemoptysis > 150 cc, pneumonia requiring hospitalization, pneumothorax requiring chest tube drainage > 7 days, mechanical ventilation > 24 hours, lung transplantation).
Time Frame
6 and 12 months
Other Pre-specified Outcome Measures:
Title
Exercise testing
Description
Comparison of the 6-min walking test between groups (using the > 25 meters change from baseline as cut-off for clinically significant change).
Time Frame
6 and 12 months months
Title
Exercise testing
Description
Comparison of the 6-min walking distance at 12 months using 54 meters as cut-off for clinically significant change.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Bilateral emphysema on Chest CT Scanner Post bronchodilator FEV1 < 50 % Total Lung Capacity > 100 % Residual Volume > 220 % Dyspnea score between 2 and 4 based on the mMRC scale Stopped cigarette smoking for more than 8 weeks Pulmonary rehabilitation within the previous twelve months Consent form signed Covered by Medical Insurance Exclusion Criteria: Post bronchodilator FEV1 < 15% Post-bronchodilator change in FEV1 > 20% Severe recurrent respiratory infections requiring more than 2 hospitalization stays within the past twelve months COPD exacerbation requiring hospital stay within 3 months Pulmonary Hypertension (Pulmonary systolic pressure >50 mmHg on cardiac echo) Patient unable to perform a 6-min walking test in room air Giant bulla of more than 1/3 of the lung field on Chest CT Strictly homogeneous emphysema on Chest CT Clinically significant bronchiectasis Past history of lobectomy, lung volume reduction surgery, lung transplantation Any extrapulmonary diseases compromising survival or evaluation within the protocol (severe cardiac disease, severe renal insufficiency, cancer…) Lung carcinoma or pulmonary nodule on CT scan requiring Chest CT scan follow-up Contra-indication to general anesthesia Oral anticoagulant treatment (antivitamin K) Allergy to nitinol Inclusion in an other study assessing respiratory treatments Patient protected by the law
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaëtan DESLEE, PhD, MD
Organizational Affiliation
CHU de Reims
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU d'Amiens
City
AMIENS Cedex 1
ZIP/Postal Code
80054
Country
France
Facility Name
CHU de Grenoble
City
GRENOBLE Cedex 9
ZIP/Postal Code
38043
Country
France
Facility Name
AP-HM
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
CHU de Montpellier
City
MONTPELLIER Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
AP-HP - Hôpital Bichat
City
PARIS Cedex 18
ZIP/Postal Code
75877
Country
France
Facility Name
CHU de Rouen
City
ROUEN Cedex
ZIP/Postal Code
76031
Country
France
Facility Name
CHU de Saint-Etienne
City
Saint-priest-en-jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Hôpitaux Universitaires de Strasbourg
City
STRASBOURG Cedex
ZIP/Postal Code
67091
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
23200592
Citation
Deslee G, Barbe C, Bourdin A, Durand-Zaleski I, Dutau H, Jolly D, Jounieaux V, Kessler R, Mal H, Pison C, Thiberville L, Vergnon JM, Marquette CH. [Cost-effectiveness of lung volume reduction coil treatment in emphysema. STIC REVOLENS]. Rev Mal Respir. 2012 Nov;29(9):1157-64. doi: 10.1016/j.rmr.2012.09.010. Epub 2012 Oct 12. French.
Results Reference
background
PubMed Identifier
30464447
Citation
Perotin JM, Leroy S, Marquette CH, Mal H, Dutau H, Bourdin A, Vergnon JM, Pison C, Barbe C, Deslee G; REVOLENS Study Group. Endobronchial coil treatment in severe emphysema patients with alpha-1 antitrypsin deficiency. Int J Chron Obstruct Pulmon Dis. 2018 Nov 5;13:3645-3649. doi: 10.2147/COPD.S176366. eCollection 2018.
Results Reference
derived
PubMed Identifier
29743071
Citation
Bulsei J, Leroy S, Perotin JM, Mal H, Marquette CH, Dutau H, Bourdin A, Vergnon JM, Pison C, Kessler R, Jounieaux V, Salaun M, Marceau A, Dukic S, Barbe C, Bonnaire M, Deslee G, Durand-Zaleski I; REVOLENS study group. Cost-effectiveness of lung volume reduction coil treatment in patients with severe emphysema: results from the 2-year follow-up crossover REVOLENS study (REVOLENS-2 study). Respir Res. 2018 May 9;19(1):84. doi: 10.1186/s12931-018-0796-x.
Results Reference
derived
PubMed Identifier
29269583
Citation
Deslee G, Leroy S, Perotin JM, Mal H, Dutau H, Bourdin A, Vergnon JM, Pison C, Kessler R, Jounieaux V, Salaun M, Marceau A, Dury S, Benzaquen J, Bonnaire M, Dukic S, Barbe C, Marquette CH; , on behalf of the REVOLENS Study Group13; REVOLENS Study Group. Two-year follow-up after endobronchial coil treatment in emphysema: results from the REVOLENS study. Eur Respir J. 2017 Dec 21;50(6):1701740. doi: 10.1183/13993003.01740-2017. Print 2017 Dec. No abstract available.
Results Reference
derived
PubMed Identifier
26757466
Citation
Deslee G, Mal H, Dutau H, Bourdin A, Vergnon JM, Pison C, Kessler R, Jounieaux V, Thiberville L, Leroy S, Marceau A, Laroumagne S, Mallet JP, Dukic S, Barbe C, Bulsei J, Jolly D, Durand-Zaleski I, Marquette CH; REVOLENS Study Group. Lung Volume Reduction Coil Treatment vs Usual Care in Patients With Severe Emphysema: The REVOLENS Randomized Clinical Trial. JAMA. 2016 Jan 12;315(2):175-84. doi: 10.1001/jama.2015.17821.
Results Reference
derived

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Lung Volume Reduction Coil Treatment in Emphysema.

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